USPTO Patents Application 10551504

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PATENT COOPERATION TREATY

PCT

INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY

(Chapter H of the Patent Cooperation Treaty)
(PCT Article 56 and Rule 70)

Applicai^'s or agent's file reference

C1-A0320Y2P

FOR FURTHER ACTION

See Form PCT/I PEA/4 16

International application No.

International filing date (day/moiilhAear)

Priority date (day/nionlh/year)

PCT/JP2004/018506

10.12.2004

12.12.2003

Internationa] Patent Classirir^tion (IPC) or national classification and IPC

C07K16/28, C12N15/11,

C12N5/06, A61K39/395

Applicant

CHUGAI SEIYAKU KABDSHIKI KAISHA

This report is the international preliminary examination report, established by this International Preliminary Examining Authority
under Article S5 and transmitted to the applicant according to Article 36.

This REPORT consists of a total of 8 sheets, including this cover sheet.

This report is also accompanied by ANNEXES, comprising:

a. □ (sent to the applicaiu and to the International Bureau) a total of

sheets, as follows:

□
□

sheets of the description, claims and/or drawings which have been amended and are the basis for this report and/or
sheets containing rectifications authorized by this Authority (see Rule 70.16 and Section 607 of the Administrative
Instructions).

sheets which supersede earlier sheets, but which this Authority considers contain an amendment that goes beyond
the disclosure in the international applic^ion as filed, as indicated in item 4 of Box No. I and the Supplemental
Box.

□

(sent to the IiUeniational Bureau only) a total of (indicate type and number of electronic C4iiricr(s))

• containing a sequence listing and/or tables
related thereto, in computer readable form only, as indicated in the Supplcmeitfal Box Relating to Sequence Listing (see
Section 802 of the Administrative Instructions).

□

This report contains indications relating to the following items:

Box No. I Basis of the report

Box No. II Priority

Box No. Ill Non-establishment of opinion with regard to novelty, inventive step and industrial applicability
Box No. IV Lack of unity of invention

Box No. V Reasoned statement under Article 35(2) with regard to novelty, inventive step or industrial applicability,
citations and explanations supporting such statement

Box No. VI Certain documents cited

Box No. VII Certain defects in the international application

Box No. VIII Certain observations on the international application

□
□
□

Date of submission of the demand

Date of completion of this report

Name and mailing address of the IPEA/JP
Facsimile No.

Authorized officer
Telephone No.

Form PCT/IPEA/409 (cover sheet) (January 2004)

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INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITi'

Iilemationa] application No.

PCT/JP2004/018506

Box No. I

Basis of the report

1. With regard to the language, this report is based on the international application in the language in which it was filed, unless otherwise
indicated under this item.

I 1 This report is based on translations from the original language into the following
' ' which is the language of a translation furnished for the purposes of:

□

international search (Rule 12.? and 2?.Ub))

□ publication of the international application (Rule 12.4)

□ international preliminary examination (Rule 5.'<.2 and/or 55.3)

2. With regard to the elements of the international application, this report is based on {replacement sheds which ha^v been furnished to the
receiving Office in response to an invitation tinder Anicle 14 are referred to in this report as " originally filed" and are not annexed to
this report):

□

the international application as originally filed/furnished
the description:

pages

pages*

pages*

as originally filed/furnished

received by this Authority on
received by this Authority on

□

the claims:

nos.

nos.*

as originally filed/furnished

as amended (together with any statement) under Article 19

nos."
nos.'

received by this Authority on
received by this Authority on

□

the drawings:

sheets

sheets*

sheets*

as originally filed/furnished

received by this Authority on
received by this Authority on

□

a sequence listing and/or any related tablets) - see Supplemental Box Relating to Sequence Listing.
The amendments have resulted in the cancellation of:

□ the description, page s

the claims, nos.

□ the drawings, sheets/figs

the sequence listing (specify):

any table(s) related to sequence listing (specify):

I I This report has been established as if (some of) the amendments annexed to this report and listed below had not been made, since
~' they have been considered to go beyond the disclosure as filed, as indicated in the Supplemental Box (Rule 70.2(c)).

□ the description, pages

□ the claims, nos.

□ the drawings, shccts/figs

the sequence listing (ipeci^>>:

□ any tabie(s) related to sequence listing (specify):

If item 4 applies, some or all of those sheets may be marked "superseded. "

Form PCT/IPEA/409 (Box No. 1» (January 2004)

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INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY

IntCTnational application No.

PCT/JP2004/018506

Box No. Ill Non-establishment of opinion wlih regard to novelty, inventive step and Industrial applicability

The questions whether the claimed invention appears to be novel, to involve an inventive step (to be non obvious), or to be industrially
applicable havz not been examined in respect of:

□

the entire irtemational application
claims Nos. 5-38

because:

□

the said internationa] application, or the said cJnims Nos.

relate to the following subject matter which does not require an international preliminary examination {^spficifyy.

□

the description, claims or drawings (indicate particular elements below) or said claims Nos.
are so unclear that no nKaningful opinion could be formed (q^cify):

□

the claims, or said claims Nos.

by the description that no meaningful opinion could be formed.

no international search report has been established for said claims Nos. 5— 3B

arc so inadequately supported

□ the niKleotidc and/or amino acid sequence listing does not comply with the standard provided for in Annex C of the Administrative
Instructions in that:

I I has not been furnished
□

docs not comply with the standard

I I has not been furnished
I I does not comply with the standard

I I the tables related to the nucleotide and/or amino acid sequence listing, if in computer readable form only, do not comply with the
technical requirements provided for in Annex C-bis of the Administrative Instructions.

I I See Supplemental Bo.v for further details.

Instructions in that:
the written form

the computer readable form

Form PCT/IPEA/409 (Box No. HI) (January 2004)

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INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY

Iiiernational application No.

PCT/JP2004/018506

Box No. IV

Lack of unity of invention

1. I I In response to the invitation to restrict or pay additional fees the applicant has:

I I restricted the claims.

I I paid additional fees.

I I paid additional fees under protest.

I I neither restricled the claims nor paid additional fees.

2. I I This Authority found that the requirement of unity of invention is not complied with and chose, according to Rule 68. 1 . not to invite

the api^licant to restrict or pay additional fees.

3. This Authority considers that the requirement of unity of invention In accordance with Rules 13.1. 13.2 and 13.3 is:
I I complied with.

not complied with for the following reasons:

The polynucleotides having a base sequence
represented by SEQ ID NOS: 1 to 65 and the
polypeptides expressed by said polynucleotides as set
forth in claim 1 do not share a common chemical
structure, and the only commonality between the
inventions set forth in the SEQ ID NOS is that
specificity is only expressed in lung cancer, stomach
cancer, cancer of the colon or hepatic cancer tissue.

However, document 1 sets forth a gene which is
specifically expressed in cancer of the colon and lung
cancer (Table 2, Co column and Lu column) .

In addition, document 2 sets forth a gene which
is specifically expressed in cancer of the colon
(Table 1) .

In addition, document 3 sets forth a gene which
is specifically expressed in hepatic cancer (Table 2) .

(Continued in Supplemental Box)

Consequently, this report has been established in respect of the following parts of the international application:
□ all parts.

the parts relating to claims Nos. 1-4

Form PCT/IPEA/409 (Box No. IV) (January 2004)

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INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY

International application No.

PCT/JP2004/018506

Box No. V Reasoned statement under Article 35(2) with regard to novelty. Inventive step or industrial applicability;
citations and explanations supportine such statement

1. Statement

Novelty (N)

Invenlive step (IS)

Claims

Claims 1 ~ 4

Claims

Claims 1 ~ 4

Industrial applicability (lA) Claims 1 ~4
Claims

\'ES
NO

YES
NO

\'ES
NO

2. Citations and explanations (Rule 70.7)

Document 1: WO 02/33072 Al (Chugai Pharmaceutical Co.,
Ltd. )

Document 2: WO 02/33073 Al (Chugai Pharmaceutical Co.,
Ltd. )

Claims 1 to 4

The invention set forth in claims 1 to 4 lacks
novelty in the light of the inventions set forth in
documents 1 and 2.

Documents 1 and 2 set forth single chain
polypeptides having bonding activity to a TPO receptor
having two heavy chain variable regions and two light
chain variable regions arranged in the order heavy chain
variable region, light chain variable region, heavy chain
variable region and light chain variable region with the
N-terminal side as a reference point, wherein the
polypeptide is bonded by linkers, and amino acids 3 to 18
are preferable as linkers, and amino acid 15 is used
(document 1, page 4, line 19 to page 5, line 20; page 9,
line 26 to page 13; line 27; page 58; fig. 34, document
2, page 4, line 27 to page 6, line 24; page 15, line 2 to
page 16, line 28; page 31; fig. 34) .

Therefore there is no discernible difference between

Form PCT/IPEA/409 (Box No. V) (January 2004)

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INTERNATIONAL PRELIMINARy REPORT ON PATENTABILITY

International application No.

PCT/JP2004/018506

Box No. V Reasoned statement under Article 35(2) with regard to novelty, inventive step or industrial applicability;

citations and explanations supporting such statement

the inventions set forth in documents 1 and 2 and the

inventions set forth in claims 1 to 4.

Form PCT/IPEA/409 (Box No. V) (January 2004)

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INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY

Inlernatioiul application No.

PCT/JP2004/018506

Supplemental Box Relating to Sequence Listing

Continuation of Box No. I, item 2:

1. With regard to any nucleotide and/or amino acid sequence disclosed in the international application and necessary to the claimed invention,
this rcp«1 was established on the basis of:

a. type of material

a sequence listing

□

b.

table(s) related to the sequence listing
format of material

□ in written format

in computer readable form
time of filing/furnishing

contained in the international application as filed

□ filed together with the international application in computer readable form

□ furnished subsequently to this Authority for the purposes of search and/or examination
received by this Authority as an amendment* on

2. I I In addilioru in the case that more than one version or copy of a sequence listing and/or tablets) relating thereto has been filed or

furnished, the required statements that the information in the subsequent or additional copies is identical to that in the application as
filed or does not go beyond the application as filed, as appropriate, were furnished.

Additional comments:

* // item 4 in Box No. I applies, the listing and/or table(s) related thereto, which form part of the basis of the report, may be marked
"superseded "

Form PCT/IPEA/409 (Supplemental Box Relating to Sequence Listing) (January 2004)

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INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY

Inernational application No.

PCT/JP2004/018506

Supplemental Box

In case the space in any of the pi^ceding boxes is not sufflcient.
Continuation of:

Therefore being specifically expressed only in lung
cancer, stomach cancer, cancer of the colon or hepatic
cancer tissue cannot be described as a special technical
feature within the meaning of PCT Rule 13.2.

Such being the case, the inventions according to the
65 SEQ ID NOS set forth in claims 1 to 27 are considered
not as a group of inventions so linked as to form a
single general inventive concept but as a group of
inventions comprising 65 inventions respectively relating
to 65 different polynucleotides and the polypeptides
expressed by these polynucleotides.

Document 1: SCHEURLE D. et al . , Cancer gene discovery

using digital differential display. Cancer
Res. (2000), Vol. 60, No. 15, pages 4037 to
4043

Document 2: Matthias P. A. E. et al.. Expression of

Metallothionein II in Intestinal Metaplasia,
Dysplasia, and Gastric Cancer, Cancer
Research {2000), Vol. 60, pages 1995 to 2001

Document 3: Xu X.R. et al . , Insight into hepatocellular
carcinogenesis at transcriptome level by
comparing gene expression profiles of
hepatocellular carcinoma with those of
corresponding noncancerous liver, Proc.
Natl. Acad. Sci. USA. (2001), Vol. 98, No.
26, pages 4037 to 4043

Form PCT/IPEA/409 (Supplemental Box) (January 2004)